Home Applications 213478 Application 213478
Type NDA
Sponsor NOBELPHARMA CO., LTD. Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HYFTOR SIROLIMUS GEL; TOPICAL 0.2% No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N213478-001 HYFTOR SIROLIMUS 0.2% GEL / TOPICAL RLD, RS 2022-03-22
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N213478-001 ODE-391 2029-03-22
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 5d02ea3f76ae…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213478-001 HYFTOR 0.2% GEL / TOPICAL RLD, RS 2022-03-22 a50c72e98297…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 51 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 73683-101 HYFTOR sirolimus Nobelpharma America, LLC NDA Current 73683-101 HYFTOR sirolimus NOBELPHARMA AMERICA, LLC NDA Current 73683-101 HYFTOR sirolimus Nobelpharma America, LLC NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 71095 ORIG 2022-05-19 70600 ORIG 2022-03-25 70590 ORIG 2022-03-23